MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG SONICWELD RX; PIN

Model Number	52-521-35-04
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	02/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Three sonicpin implants were implanted to fixate rib grafts to the left and right condylar head.This was completed successfully and patient was put in rubber bands instead of wiring jaw shut which allowed some movement post operatively.During post-op consults that evening and next day the patient was progressing well.Upon rounds on 2nd day post-op patients occlusion had opened and after review of the ct scan it was apparent the fixation had failed.Patient underwent another operation this time implanting bicotrical and monocortical resorb-x pins and resorb-xg plates.The patient has a titanium allergy.
Additional Manufacturer Narrative
An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The complaint percentage was calculated and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.The product device history records were also reviewed based on the lot number provided, and no anomalies were found.Due to no device being returned the root cause for the failure cannot be determined.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

• Brand Name: SONICWELD RX
• Common Device Name: PIN
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6373188
• Report Number: 9610905-2017-00026
• Device Sequence Number: 735599
• Product Code: JEY
• UDI-Device Identifier: 10888118001143
• UDI-Public: (01)10888118001143
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K080862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 52-521-35-04
• Device Lot Number: 32017055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2017
• Supplement Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR